THE TETHER

Company
Zimmer Biomet Spine (now Highridge Medical)

Timeframe
2017-2018

Role
Primary NPD Quality Engineer

Project Goal
The Tether is an innovative, non-fusion spinal device designed to treat pediatric patients with progressive idiopathic scoliosis. Unlike traditional spinal fusion surgeries, The Tether allows for continued spinal growth and mobility, offering a motion-preserving alternative for patients unresponsive to bracing.

Risk Management & Compliance

Owned and maintained the risk management file for the project, facilitating risk assessment meetings and integrating findings from cadaveric simulated use testing.

Design History File (DHF) Oversight

Led the compilation and management of Quality deliverables to the DHF, ensuring all design and development processes were thoroughly documented in compliance with regulatory standards.

Sterilization & Cleanability Validation

Conducted comprehensive testing of instrument cleanability and sterilization to ensure patient safety and meet stringent regulatory requirements.

Leadership & Mentorship

Facilitated weekly quality-focused meetings, coordinating action items and reporting progress to the project lead. Mentored a junior quality engineer in performing Biologic Risk Assessments, fostering skill development within the team.

Contributions

Regulatory Success

Successfully navigated the unique challenges of the HDE regulatory pathway, contributing to the FDA approval of The Tether as a first-of-its-kind treatment for pediatric scoliosis.

The Tether received FDA approval through the HDE pathway, a process reserved for devices treating conditions affecting fewer than 8,000 individuals annually in the U.S. This pathway required a tailored regulatory approach, with specific documentation and testing protocols.

Clinical impact

Clinical data demonstrated that, at two years post-implantation, 43 out of 57 patients experienced sufficient improvement in spinal curvature, eliminating the need for spinal fusion surgery—preserving spinal mobility and improving quality of life for pediatric patients.